SEPRAFILM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-09-10 for SEPRAFILM manufactured by Genzyme Corporation(framingham).

Event Text Entries

[157092487] Allergic reaction (including several overlapping events) [allergic reaction] ([eosinophil count increased], [fibroblast growth factor 23 increased]). Case narrative: initial information received on 27-aug-2019 regarding an unsolicited valid serious case received from (b)(6) other sanofi-(b)(4) group employee under reference on and transmitted to sanofi. This case involves a (b)(6) years old male patient who experienced allergic reaction (including several overlapping events), while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm]. The patient's past medical history included gastrectomy in (b)(6) 2019. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing gastric cancer. In (b)(6) 2019, the patient with gastric cancer underwent pylorogastrectomy and seprafilm (size: 1 pack) was applied under the incision. On an unknown date, after hospitalization for 10 days, the patient was discharged from the hospital. After rehospitalization, the patient died. The findings showed eosinophils increased and proliferation of fibroblasts in the abdominal cavity. Allergic reaction (including several overlapping events) to seprafilm used during surgery developed. On an unknown date, the outcome of allergic reaction (including several overlapping events), eosinophils increased, and proliferation of fibroblasts was fatal. The patient developed an event of a serious allergic reaction (including several overlapping events) (hypersensitivity). This event was leading to death. The patient was hospitalized for this event. The patient developed an event of a serious eosinophils increased (eosinophil count increased). This event was leading to death. The patient was hospitalized for this event. The patient developed an event of a serious proliferation of fibroblasts (fibroblast growth factor 23 increased). This event was leading to death. The patient was hospitalized for this event. Final diagnosis was (fatal) severe allergic reaction (including several overlapping events). It was not reported if the patient received a corrective treatment. The patient outcome is reported as fatal on an unknown date for allergic reaction (including several overlapping events), as fatal on an unknown date for eosinophils increased and as fatal on an unknown date for proliferation of fibroblasts. It is unknown if an autopsy was done. The cause of death was reported as hypersensitivity. Reporter comment: causality between seprafilm and allergic reaction (including several overlapping events): unknown. Possible causative factors for adverse events other than seprafilm: unknown. Additional information was received on 29-aug-2019: investigation summary was received.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220423-2019-00022
• MDR Report Key: 8980010
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-09-10
• Date of Report: 2019-10-11
• Date Added to Maude: 2019-09-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. HEATHER SCHIAPPACASSE
• Manufacturer Street: 55 CORPORATE DRIVE, MS 55B-220 A
• Manufacturer City: BRIDGEWATER 08807
• Manufacturer Country: US
• Manufacturer Postal: 08807
• Manufacturer G1: GENZYME CORPORATION(FRAMINGHAM)
• Manufacturer Street: 76 NEW YORK AVENUE
• Manufacturer City: FRAMINGHAM 01701
• Manufacturer Country: US
• Manufacturer Postal Code: 01701
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SEPRAFILM
• Generic Name: MCN
• Product Code: MCN
• Date Received: 2019-09-10
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GENZYME CORPORATION(FRAMINGHAM)
• Manufacturer Address: 76 NEW YORK AVENUE FRAMINGHAM 01701 US 01701

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Hospitalization	2019-09-10